Sensys Medical, Inc.

Instrumentation Metrics, Inc.

Glt Acquisition Corp.

Thomas B Blank

Timothy Lewis Ruchti

Stephen L Monfre

Kevin H Hazen

Alexander D Lorenz

George M Acosta

Mutua Mattu

Marcy R Makarewicz

James Ryan Henderson

Suresh Thennadil

Brian Jeffrey Wenzel

Roxanne E Abul-Haj

Christopher Slawinski

Stephen F Malin

Timothy Stippick

Jessica Rennert

N Alan Abul-Haj

Tamara L Troy

Ken Meissner

Frank S Grochocki

Suresh N Thennadil

N Alan Abul Haj

James Matthew Welch

Alan Abul-Haj

Linda J Hockersmith

Benjamin Richie

Tim Stippick

Suresh N Thennadill

Edward Handy

Tim Ruchti

William Hay

Christopher C Briggs

Branden Rosenhan

Sedar R Brown

Donovan D Berry

The invention relates generally to a probe interface method and apparatus for use in conjunction with an optical based noninvasive analyzer. More particularly, an algorithm controls a sample probe position and attitude relative to a skin sample site before and/or during sampling. For example, a sample probe head of a sample module is controlled by an algorithm along the normal-to-skin-axis. Preferably, the sample probe head is positioned in terms of 3-D location in the x-, y-, and z-axes and is attitude orientated in terms of pitch, yaw, and roll. Further, attitude of the probe head is preferably orientated prior to contact of the sample probe head with the tissue sample using indicators, such as non-contact distance feedback from capacitance sensor, contacting or non-contacting optical sensors, and/or contact electrical sensors.

Method and apparatus for controlling positioning of a noninvasive analyzer sample probe

The invention comprises method and apparatus for fluid delivery between a sample probe and a sample. The fluid delivery system includes: a fluid reservoir, a delivery channel, a manifold or plenum, a channel or moat, a groove, and/or a dendritic pathway to deliver a thin and distributed layer of a fluid to a sample probe head and/or to a sample site. The fluid delivery system reduces sampling errors due to mechanical tissue distortion, specular reflectance, probe placement, and/or mechanically induced sample site stress/strain associated with optical sampling of the sample.

Method and apparatus for coupling a sample probe with a sample site

Sampling is controlled in order to enhance analyte concentration estimation derived from noninvasive sampling. More particularly, sampling is controlled using controlled fluid delivery to a region between a tip of a sample probe and a tissue measurement site. The controlled fluid delivery enhances coverage of a skin sample site with the thin layer of fluid. Delivery of contact fluid is controlled in terms of spatial delivery, volume, thickness, distribution, temperature, and/or pressure.

Method and apparatus for coupling a channeled sample probe to tissue

The invention involves the monitoring of a biological parameter through a compact analyzer. The preferred apparatus is a spectrometer based system that is attached continuously or semi-continuously to a human subject and collects spectral measurements that are used to determine a biological parameter in the sampled tissue. The preferred target analyte is glucose. The preferred analyzer is a near-IR based glucose analyzer for determining the glucose concentration in the body.

Compact apparatus for noninvasive measurement of glucose through near-infrared spectroscopy

A method of multi-tier classification and calibration in noninvasive blood analyte prediction minimizes prediction error by limiting co-varying spectral interferents. Tissue samples are categorized based on subject demographic and instrumental skin measurements, including in vivo near-IR spectral measurements. A multi-tier intelligent pattern classification sequence organizes spectral data into clusters having a high degree of internal consistency in tissue properties. In each tier, categories are successively refined using subject demographics, spectral measurement information and other device measurements suitable for developing tissue classifications. The multi-tier classification approach to calibration utilizes multivariate statistical arguments and multi-tiered classification using spectral features. Variables used in the multi-tiered classification can be skin surface hydration, skin surface temperature, tissue volume hydration, and an assessment of relative optical thickness of the dermis by the near-IR fat band. All tissue parameters are evaluated using the NIR spectrum signal along key wavelength segments.

Multi-tier method of developing localized calibration models for non-invasive blood analyte prediction

The invention provides a targeting system used to direct a measuring system to a targeted sample site or volume. The targeting system increases analyte estimation performance by increasing precision and accuracy of sampling and/or by targeting an analyte rich tissue volume.

Noninvasive targeting system method and apparatus

This invention provides a method and apparatus that corrects for tissue related interference calibration and/or measurement of biological parameters noninvasively. The invention concerns such terms as outlier identification, filtering, spectral correction, and baseline subtraction steps that, when used together, provides for noninvasive measurement of biological parameters, such as glucose concentration.

Method of processing noninvasive spectra

An optical sampling interface system is disclosed that minimizes and compensates for errors that result from sampling variations and measurement site state fluctuations. Embodiments of the invention use a guide that does at least one of, induce the formation of a tissue meniscus, minimize interference due to surface irregularities, control variation in the volume of tissue sampled, use a two-part guide system, use a guide that controls rotation of a sample probe and allows z-axis movement of the probe, use a separate base module and sample module in conjunction with a guide, and use a guide that controls rotation. Optional components include an occlusive element and a coupling fluid.

Optical sampling interface system for in-vivo measurement of tissue

A method and apparatus are provided for noninvasive sampling. More particularly, the method and apparatus relate to control of motion of an optical sample probe interface relative to a tissue sample site. A dynamic probe interface, is used to collect spectra of a targeted sample, control positioning of the sample probe relative to the tissue sample in terms of at least one of x-, y-, and z-axes, and/or control of sample tissue displacement to minimize spectral variations resulting from the sampling process and increase analyte property estimation precision and accuracy.

Noninvasive analyzer sample probe interface method and apparatus

A method and apparatus for noninvasive glucose measurement measures glucose indirectly from the natural response of tissue to variations in analyte concentration. The indirect measurement method utilizes factors affected by or correlated with the concentration of glucose, such as refractive index, electrolyte distribution or tissue scattering. Measurement reliability is greatly improved by stabilizing optical properties of the tissue at the measurement site, thus blood perfusion rates at the sample site are regulated. Perfusion is monitored and stabilized by spectroscopically measuring a control parameter, such as skin temperature, that directly affects perfusion. The control parameter is maintained in a range about a set point, thus stabilizing perfusion. Skin temperature is controlled using a variety of means, including the use of active heating and cooling elements, passive devices, such as thermal wraps, and through the use of a heated coupling medium having favorable heat transfer properties.

Method and apparatus for control of skin perfusion for indirect glucose measurement

A placement guide apparatus with an improved hydration inducing plug used in coupling a noninvasive analyzer to a sampling site to determine analyte in the human body is disclosed. The hydration inducing plug includes at least one fluoropolymer that may be used as a coupling agent. The guide apparatus may further include an automated or semi-automated coupling fluid delivery system. Use of either of these couplers mitigates issues associated with related technology and enhances noninvasive analyte measurements, such as a near-IR diffuse reflectance based noninvasive glucose concentration analyzer.

Apparatus and method for easing use of a spectrophotometric based noninvasive analyzer

A method and apparatus for easing the use of an optically based noninvasive analyzer is presented. More particularly, a simplified algorithm is used that removes the daily requirement of collecting and using a noninvasive spectrum to update a calibration model. In another embodiment, a guide is used to substantially reduce variation in sample probe placement in relation to a skin tissue sampling site, resulting in the ability to maintain calibration performance with the use of a reference analyte concentration, with or without the use of a reference spectrum collected nearby in time.

Method of sample control and calibration adjustment for use with a noninvasive analyzer

A near IR spectrometer-based analyzer attaches continuously or semi-continuously to a human subject and collects spectral measurements for determining a biological parameter in the sampled tissue, such as glucose concentration. The analyzer includes an optical system optimized to target the cutaneous layer of the sampled tissue so that interference from the adipose layer is minimized. The optical system includes at least one optical probe. Spacing between optical paths and detection fibers of each probe and between probes is optimized to minimize sampling of the adipose subcutaneous layer and to maximize collection of light backscattered from the cutaneous layer. Penetration depth is optimized by limiting range of distances between paths and detection fibers. Minimizing sampling of the adipose layer greatly reduces interference contributed by the fat band in the sample spectrum, increasing signal-to-noise ratio. Providing multiple probes also minimizes interference in the sample spectrum due to placement errors.

An optical sampling interface system minimizes and compensates error resulting from sampling variations and measurement site state fluctuations. Components include: An optical probe placement guide having an aperture wherein the optical probe is received, facilitates repeatable placement accuracy on surface of a tissue measurement site with minimal, repeatable disturbance to surface tissue. The aperture creates a tissue meniscus that minimizes interference due to surface irregularities and controls variation in tissue volume sampled; an occlusive element placed over the tissue meniscus isolates the meniscus from environmental fluctuations, stabilizing hydration at the site and thus, surface tension; an optical coupling medium eliminates air gaps between skin surface and optical probe; a bias correction element applies a bias correction to spectral measurements, and associated analyte measurements. When the guide is replaced, a new bias correction is determined for measurements done with the new placement. Separate components of system can be individually deployed.

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Chandler, AZ, United States of America

Thomas B Blank